Comparison · NCT01465464-sae
Orantinib vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Orantinib vs Placebo: serious adverse events. Trial comparisons, record NCT01465464-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01465464-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.45 | 0.405 | 0.497 | wilson | |
| Risk in group 2 | 0.302 | 0.261 | 0.346 | wilson | |
| Risk difference, group 1 minus group 2 | 0.149 | 0.0851 | 0.211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 1.25 | 1.78 | log | |
| Odds ratio, group 1 over group 2 | 1.9 | 1.44 | 2.5 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Orantinib than on Placebo | 6.73 | 4.75 | 11.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Orantinib | Orantinib (TSU-68): 200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening. | 200 | 444 | EG000 |
| Group 2 | Placebo | Placebo: 1 tablet was administered orally twice per day after meals, morning and evening. | 134 | 444 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the date of the first treatment to 30 days after the last treatment
Source ClinicalTrials.gov
Trial
- Title
- Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma
- NCT number
- NCT01465464
- Phases
- PHASE3
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Orantinib (TSU-68), Placebo
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Results first posted
- 2019-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01465464?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01465464-sae